正文
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Thisdocument is a summary of the ten most frequent questions raised after theinitial evaluation of new applications for Certificates of suitability (CEP)for chemical purity. It is based on the content of a sample of 20 deficiencyletters sent selected randomly during the second half of 2015 and beginning of2016.
本文是对化学纯度CEP新申报资料初次审评中发现的最常见十大问题的总结。该总结是基于2015年下半年和2016年初期间随机抽取的20封缺陷信内容。
The topten most frequent questions are listed below together with expectations andrecommendations on how to address the specific deficiencies, with reference toapplicable guidelines.
以下列出了十大最常见问题，以及EDQM期望和建议如何解决这些缺陷和相关的适用指南。
Thisdocument is intended to help applicants to improve the quality of theirdossiers, in order to facilitate and speed up the granting of their CEPs. Itshould be taken into account while building up a dossier, in combination withthe EDQM Guideline “Content of the Dossier for Chemical Purity andMicrobiological Quality (PA/PH/CEP 04 1)” available on the EDQM website.
本文意在帮助申报人提高其注册文件质量，以帮助和加快其CEP的颁发。在构建注册文件时，应结合考虑EDQM官网上EDQM指南“化学纯度和微生物质量注册文件内容（PA/PH/CEP04 1）”的要求。
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TOP 1
(S.3.2)
第一位
（
S.3.2
）
Absence or deficient discussion on the risk of having potential mutagenic impurities in the final substance.
原料药成品中潜在诱变性杂质风险讨论缺失或有缺陷。
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This isapplicable to sources of substances which have not yet been introduced inmedicinal products available on the European market.
